Nearly one in nine adults—around 11 percent of the population—struggle with chronic insomnia, and the fallout extends far beyond just feeling tired. Untreated insomnia can increase the risk of serious health problems like diabetes and heart disease, and it’s a real drag on daily life, impacting everything from concentration to mood. But figuring out if a sleep aid *actually* works for an individual has always been a bit of a guessing game.
Now, researchers at the University of Maryland School of Medicine believe they’ve found a way to get a more precise read: real-time assessments via smartphone. A new study published in JAMA Network Open shows that tracking daytime symptoms—like fatigue, cognitive function, and mood—multiple times a day can reveal how well sleep medications are working, offering a more nuanced picture than traditional recall-based questionnaires.
Smartphone Data Reveals Subtle Treatment Effects
Can a smartphone really tell us more about how well a sleep aid is working than simply asking someone how they feel? The answer, according to this research, is a resounding yes. Traditional questionnaires can show whether insomnia severity improves overall, but they often miss subtle shifts in daytime functioning that patients find crucial.
The clinical trial involved 40 adults between the ages of 60 and 85 with chronic insomnia. Participants were randomly assigned to receive either suvorexant or a placebo for 16 nights. Throughout the study, all participants used a smartphone app to log their daytime symptoms four times each day. They also completed standard sleep questionnaires before and after the treatment period.
The smartphone-based approach, called ecological momentary assessment (EMA), revealed key differences between the groups. Compared to the placebo, suvorexant was associated with lower alertness early in the day, but cognitive function normalized as the day progressed. While participants taking suvorexant reported slightly worse moods throughout the day, the difference wasn’t statistically significant.
Importantly, participants found the smartphone assessment easy to use, with a completion rate of 93.3 percent, suggesting it’s a feasible and engaging method for gathering data.
“Daytime symptoms such as fatigue, cognitive impairment, and mood disturbances are core features of insomnia,” explained Emerson M. Wickwire, PhD, faculty member at the University of Maryland School of Medicine and section chief of sleep medicine at the University of Maryland Medical Center. “Improving sleep is not enough. We need to determine how well treatments improve daytime functioning, which patients report matters most. In this study we found that retrospective questionnaires failed to detect subtle treatment-related changes that were detected via the smartphone assessment.”
What This Means for Patients and Doctors
This is the first randomized controlled trial to use smartphone EMA as a primary outcome measure in a sleep study. The findings suggest that leveraging smartphones and wearable technology for real-time, multi-method assessments could revolutionize how sleep treatments are evaluated—and potentially extend to other sleep disorders like obstructive sleep apnea and excessive sleepiness.
“These findings address a critical gap in sleep disorders clinical care and research,” Dr. Wickwire said. “When viewed as a complement to traditional approaches, EMA offers a sensitive and patient-centered way to measure treatment effects throughout the day, in real-time. Such approaches could transform how we evaluate sleep treatments, personalize sleep medicine care, and ultimately improve outcomes for the millions of Americans with sleep disorders.”
Co-authors on the study included Shuo Chen, PhD, Professor of Epidemiology & Public Health at UMSOM; Avelino Verceles, MD, MS, Professor of Medicine at UMSOM; and University of Maryland graduate student Jingsong Zhou, MS. The study was supported by a research grant from the Investigator-Initiated Studies Program of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co, Inc.
“This research underscores the potential for innovative digital tools to be used in conducting comparative effectiveness studies,” said UMSOM Dean Mark T. Gladwin, MD, who is also the Vice President for Medical Affairs, University of Maryland, Baltimore (UMB), and the John Z. and Akiko K. Bowers Distinguished Professor and Dean at UMSOM. “Smartphone-based assessments can provide real-time insights that help improve patient outcomes across a range of common conditions.”
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